Pelvic Organ Prolapse (POP), Cystocele, Pelvic Floor Disorder
Conditions
Keywords
regenerative medicine, biostimulant, tissue regeneration, pelvic floor disorder, pelvic organ prolapse, cystocele
Brief summary
Pelvic organ prolapse (POP) is a condition characterized by descent of vaginal walls, uterus and cervix, or the perineum and causes a sensation of vaginal bulge and pelvic pressure. Millions of women in the United States are affected, and the number is expected to rise significantly in the coming decades. Current treatments either involve conservative measures or surgery. Surgery may lead to changes in vaginal topography and scar tissue, both of which impact sexual function. There are no treatment options that restore vaginal tissue strength and preserve, even optimize, sensation and blood flow to the vagina. This project will evaluate the use of poly-L-lactic acid (PLLA), an FDA-approved biostimulant for dermatologic use with an expansive safety profile over the past decade, in the treatment of anterior wall POP and its impact on sexual function. Our study will compare intravaginal injection of PLLA vs. placebo in women with stage 2 cystocele and investigate safety and preliminary efficacy of PLLA. Prior study of regenerative biologics for the vulva and vagina have shown great promise, but use of these has not been explored for POP. This randomized controlled trial has the potential to shift the paradigm of prolapse management from surgical reconstruction to regeneration. This shift will prevent the risks of surgery and has the potential to improve sexual function and quality of life by resolving POP.
Interventions
Sculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina
OTHERPlacebo injection (sterile water)
8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina
Sponsors
Cassandra Kisby
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 21 * Stage II POP of anterior vaginal wall (Ba ≥ -1) * Symptomatic bulge symptoms * Positive response to PFDI-20 question 3: Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? * AND any degree of bother. Providing any answer other than "not at all" to "how much does this bother you" * Abstinent, on contraception, or postmenopausal at time of injection * Must read or understand English
Exclusion criteria
* Concurrent apical or posterior prolapse \> stage 1 * Prior pelvic radiation * Previous vaginal reconstructive surgery (Except total vaginal hysterectomy or sling) * History of chronic vaginal infections (ex. Sexually transmitted infection or bacterial vaginosis) * Prior vaginal laser treatment \< 6 months * Planned vaginal laser/topical treatment * History of hypertrophic reaction to vicryl (polyglactin-910) * Allergy to Sculptra aesthetic or any components of Sculptra (PLLA, carboxymethylcellulose, non-pyrogenic mannitol) * Allergy to silicone * Premenopausal without contraception or abstinence during treatment phase * Currently breastfeeding * Connective tissue disorder * Uncontrolled diabetes (defined as HbA1c \> 8) * Does not read or understand English * Inability to provide informed consent * Physical limitations that would prevent subjects from performing the required pelvic wand massage sessions after each injection, such as significant arthritis or other mobility limitations. * Prescription anticoagulation therapy that cannot be safely discontinued (Aspirin and anti-platelet therapies would be considered acceptable) * Current use of other treatments for prolapse, such as pessary, in subjects who are unwilling to discontinue these treatments during the study period. * Planning to start pelvic floor physical therapy during the study * Undergoing physical therapy and not willing to stop internal therapy for 2 weeks after an injection or biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events between groups | We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months) | The investigators will assess the number of adverse events between groups using Clavien Dindo classification system (Grade I-V) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Organ Prolapse Quantification Point Ba Between Groups | 9 months | The investigators will assess Ba (maximum descent of the anterior vaginal wall) values between intravaginal PLLA vs. placebo injection groups at initial visit, 1 month, 2 months, 6 months, and 9 months after injection. They will use linear regression models controlling for baseline Ba. |
| Patient Reported Pelvic Symptoms (PFDI-20) | 9 months | Pelvic Floor Disability Index (PFDI-20) is a short form of the Pelvic Floor Distress Inventory. It is a patient reported outcome measure assessing bowel, bladder, or pelvic symptoms and severity of symptoms. It has a total score ranging from 0 to 300 (higher scores indicate greater distress) |
| Patient Reported Pelvic Symptoms (Vaginal health) | 9 months | Vaginal health: Vulvovaginal Symptoms Questionnaire (VSQ) measures vulvovaginal health via a series of yes and no questions. The total score ranges from 0 to 16 for sexually inactive women and 0 to 20 for sexually active women, with higher scores indicating greater symptom severity. |
| Patient Reported Pelvic Symptoms (Sexual function) | 9 months | Sexual function: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) is used to assess patient reported sexual function in individuals with pelvic floor disorders. Items are generally answered on a 0-4 Likert scale, with higher scores indicating better sexual function for sexually active women and lower impact on sexual inactivity for non-sexually active women. |
| Patient Reported Pelvic Symptoms (Body Image) | 9 months | Body Image in Women with Pelvic Organ Prolapse (BIPOP) is a self-reported outcomes questionnaire used to assess how prolapse affects a woman's body image. It is scored on a 1-5 scale based on 10 items, where higher mean scores (1-5) indicate a worse prolapse-related body image. |
| Quality of Life Questionnaires (SF-12) | 9 months | Global: Short-Form 12 Health Survey (SF-12) uses a scale 0-47. It is scored using complex, weighted algorithms that aggregate 12 items into two main composite scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS). Using norm-based scoring, scores are transformed to have a mean of 50 and a standard deviation of 10, where a score \> 50 indicates better-than-average health. |
| Quality of Life Questionnaires (PFIQ-7) | 9 months | Disease specific: urinary, bowel, and prolapse scales of Pelvic Floor Impact Questionnaire (PFIQ-7) evaluates patient reported impact of pelvic organ prolapse on quality of life. s scored by assigning a value from 0 to 3 for each of the seven questions across three subscales (0="Not at all", 3="Quite a bit"). Subscale scores are calculated by obtaining the mean of answered items, then multiplying by to achieve a 0-100 range. The total PFIQ-7 score is the sum of the three subscales (0-300), where lower scores indicate better quality of life. |
| Tissue Histology | 6 months | The investigators will evaluate histology (tissue) level changes between groups via a vaginal biopsy at baseline and at 6 months. |
Countries
United States
Contacts
CONTACTCassandra Kisby, MD MS FACOG FACS
CONTACTDuke Urogynecology Clinical Research Coordinators
PRINCIPAL_INVESTIGATORCassandra Kisby, MD MS FACOG FACS
Duke University
Outcome results
None listed